SPRINT - Randomized Trial of Tibial Fracture Fixation

The purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

Patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. These patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. Time to healing, as well as repeat interventions and adverse events, will be tracked. The rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Participants will receive reaming of the intramedullary canal prior to insertion of an intramedullary nail.

Participants will receive insertion of an intramedullary nail without prior reaming of the intramedullary canal.

Insertion of an intramedullary nail during tibial fracture fixation with or without prior reaming of the intramedullary canal.

Swiontkowski M, Teague D, Sprague S, Bzovsky S, Heels-Ansdell D, Bhandari M, Schemitsch EH, Sanders DW, Tornetta P, Walter SD; SPRINT Investigators. Impact of centre volume, surgeon volume, surgeon experience and geographic location on reoperation after intramedullary nailing of tibial shaft fractures. Can J Surg. 2021 Jul 5;64(4):E371-E376. doi: 10.1503/cjs.004020.

Khan JS, Devereaux PJ, LeManach Y, Busse JW. Patient coping and expectations about recovery predict the development of chronic post-surgical pain after traumatic tibial fracture repair. Br J Anaesth. 2016 Sep;117(3):365-70. doi: 10.1093/bja/aew225.

Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Kulkarni AV, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators & the Medically Unexplained Syndromes Study Group. Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. J Orthop Trauma. 2012 Jun;26(6):370-8. doi: 10.1097/BOT.0b013e31822421e2.

SPRINT Investigators; Briel M, Sprague S, Heels-Ansdell D, Guyatt G, Bhandari M, Blackhouse G, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Walter SD, Goeree R. Economic evaluation of reamed versus unreamed intramedullary nailing in patients with closed and open tibial fractures: results from the study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (SPRINT). Value Health. 2011 Jun;14(4):450-7. doi: 10.1016/j.jval.2010.10.034. Epub 2011 May 25. Erratum In: Value Health. 2011 Sep-Oct;14(6):963. multiple investigator names added.

Busse JW, Bhandari M, Guyatt GH, Heels-Ansdell D, Mandel S, Sanders D, Schemitsch E, Swiontkowski M, Tornetta P 3rd, Wai E, Walter SD; SPRINT Investigators. Use of both Short Musculoskeletal Function Assessment questionnaire and Short Form-36 among tibial-fracture patients was redundant. J Clin Epidemiol. 2009 Nov;62(11):1210-7. doi: 10.1016/j.jclinepi.2009.01.014. Epub 2009 Apr 11.

SPRINT Investigators; Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskelet Disord. 2008 Jun 23;9:91. doi: 10.1186/1471-2474-9-91.